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Deals:
Novartis is set to acquire Tourmaline Bio for $1.4 billion.
Servier buys Medicxi startup’s fragile X candidate for up to $450 million.
Sandoz and Regeneron reached an agreement, resolving all patent litigation related to its U.S. aflibercept biosimilar.
Vitality announced a new GPO agreement with the Health Plan Alliance.
Cliniphai and Gibson Research Consultancy announced a partnership.
FDA:
The FDA launched a green list to protect Americans from illegally imported GLP-1 drug ingredients.
The agency cleared eGenesis to launch the first U.S. clinical trial of gene-edited pig kidneys for patients with end-stage kidney disease.
The FDA approved an expanded indication for Takeda’s Vonvendi [von Willebrand factor (Recombinant)] for adults and children with von Willebrand disease.
Ionis Pharmaceuticals received a Breakthrough Therapy designation for ION582 in Angelman syndrome.
PMV is set to pursue FDA approval in ovarian cancer.
Johnson & Johnson received FDA approval of Inlexzo (gemcitabine intravesical system) for certain bladder cancers.
The FDA issued a new guidance to expand non-opioid options for chronic pain.
Indian drugmaker Sun Pharmaceutical Industries said the FDA determined its Halol plant in Gujarat was not compliant with the regulator’s manufacturing rules.
Funding rounds:
Henry Schein announced a $750 million share repurchase plan.
LB Pharma raises $285 million in Nasdaq debut.
Odyssey Therapeutics raised a $213 million Series D funding round.
CAMP4 Therapeutics announced an oversubscribed private placement of up to $100 million.
YolTech Therapeutics raised a $44.5 million Series B funding round.
Silexion Therapeutics priced a $6 million public offering.
Layoffs:
Novo Nordisk is cutting some 9,000 staff across its global operations in a bid to generate around $1.25 billion in annualized savings through 2026.
Merck is scrapping its $1.3 billion plans in the U.K. and laying off 125 employees there.
Industry news:
Eli Lilly launched TuneLab platform to give biotechnology companies access to AI-enabled drug discovery models built through over $1 billion in research investment.
Dianthus Therapeutics said its experimental treatment for myasthenia gravis achieved the primary goals of a Phase 2 study.
Pfizer and BioNTech reported top-line Phase 3 study results showing their COVID-19 vaccine Comirnaty elicited an immune response against the most prevalent circulating strain of the SARS-Cov-2 virus.
Rapport Therapeutics posted topline mid-stage data indicating that its epilepsy pill can cut seizure frequency.
IPG Health expanded its Influencer ID marketing program into Europe.
Alkermes reported promising results for an experimental narcolepsy drug.
Lilly’s blood drug Jaypirca helped delay progression of certain lymphomas in a late stage trial.
Johnson & Johnson said its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) prevents acquired resistance versus osimertinib in first-line EGFR-mutated non-small cell lung cancer.
AstraZeneca said its Tagrisso plus chemotherapy demonstrated a median overall survival of nearly four years in a global Phase III trial for EGFR-mutated advanced lung cancer.
Within3 Insights unveiled its Launch Intelligence and Know Everything solutions.
Havas Health Network expanded into Taiwan.
Amgen and Kyowa Kirin reported positive rocatinlimab results in an eczema trial.
The World Health Organization declared an end of global emergency over mpox outbreak.
The American Academy of Family Physicians recommended that all adults over 18, as well as children and pregnant women, get COVID vaccines.
Regeneron said Libtayo (cemiplimab) plus chemotherapy results at five years reinforce significant and durable improvements in survival outcomes for advanced non-small cell lung cancer.
Doceree launched RepTwin.
Legendairy Milk dropped Bloat Baddie, its newest 3-in-1 daily digestive capsule.
Eversana was named U.S. commercialization partner for Precigen’s launch of Papzimeos.
To read last week’s edition of Rx Rundown, click here.